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By Bekki Thomas and Megan McMahon

Rebecca Thomas-finalMegan McMahon-finalThe pharmaceutical industry and the Food and Drug Administration (FDA) share an interest in the generation of marketing applications that are clear and concise with a focus on risk discussions that provide confidence in quality.

Risk-based approaches were first introduced by FDA and ICH Guidance Q8, Q9, Q10, Q11, and draft Q12. Many international markets are acting as observers to the ICH and developing guidance based on risk-based approaches. Industry wants the flexibility to improve products over their lifecycle with reliability of supply for a global market.

A theme of the 2015 AAPS Annual Meeting is Regulatory Challenges Affecting Global Community, and related to that theme, the AAPS Regulatory Sciences section will host the open forum Science and Risk Based Assessment for Global Product Commercialization: CMC and Regulatory Considerations on October 29, chaired by us.

There will be an interactive discussion focused on the following key themes: a comprehensive and patient focused approach to developing a target product profile and associated quality target product profile; results from risk assessments of manufacturing process effects on product quality attributes; elements of the product control strategy; and the established conditions should be summarized within the common technical document and reference the specific locations. A discussion of the location of the summary information within the CTD will be developed for further consideration. The summary may serve as the source for identifying the regulatory commitments when deciding on the appropriate reporting category for post approval changes within a lifecycle management plan.

This topic is very timely and of critical importance since regulatory guidance is currently developing in many markets. The session will include an update on the development of ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle.

Don’t miss this unique opportunity to discuss recent developments including the draft FDA Guidance of Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products (PDF) and an update on the ANVISA resolution for post approval changes, which is currently awaiting director board approval.

Bekki Thomas is a CMC regulatory executive with over 30 years’ experience and president of Bekki Thomas Consulting, LLC. She is experienced with global CMC requirements specializing in Latin America and emerging requirements.
Megan McMahon is an associate director in Global Regulatory CMC at Pfizer, Inc. She develops regulatory strategy and ensures compliance for investigational and marketed new chemical entities.